Determine the pharmacokinetics, including the terminal elimination serum half-life area under the curve and volume of distribution, of recombinant BL22 immunotoxin in these patients.

Determine the immunogenicity of recombinant BL22 immunotoxin in these patients.

Determine the effect of recombinant BL22 immunotoxin on various components of the circulating cellular immune system in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Patients may be retreated at least every 20 days for up to 25 courses in the absence of disease progression and sufficient neutralizing antibodies.

Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Failed prior standard chemotherapy and treatment is medically indicated as evidenced by the following:

Progressive disease-related symptoms

Progressive cytopenias due to marrow involvement

Progressive or painful splenomegaly or adenopathy

Rapidly increasing lymphocytosis

Autoimmune hemolytic anemia or thrombocytopenia

Increased frequency of infections OR

Confirmed CD22+ B-cell indolent non-Hodgkin's lymphoma

Stages II-IV that have failed at least 1 prior standard therapy and treatment is medically indicated

No patients whose serum neutralizes BL22 or PE38 in tissue culture, due to antitoxin or antimouse-IgG antibodies

No central nervous system disease requiring treatment

If the patient is non-leukemic, the absolute neutrophil count must be greater than 1,000/mm3 and the platelet count greater than 40,000/mm3

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

More than 6 months

Hematopoietic:

See Disease Characteristics

Hepatic:

ALT and AST less than 5 times upper limit of normal

Renal:

Adequate renal function

Pulmonary:

Adequate pulmonary function

Other:

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Prior bone marrow transplantation allowed

At least 3 weeks since prior interferon for malignancy

Chemotherapy:

See Disease Characteristics

At least 3 weeks since prior cytotoxic chemotherapy for malignancy

Endocrine therapy:

Not specified

Radiotherapy:

At least 3 weeks since prior radiotherapy for malignancy

Surgery:

Not specified

Other:

At least 3 weeks since prior retinoids

At least 3 weeks since prior systemic therapy for cancer

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024115